FDA.reportPublic FDA data

Application 205186

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDETABLET;ORALEQ 20MG BASENoNo
002ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-039eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma USA Inc.ANDACurrent
27241-039eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-039eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-039eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-039eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-039eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-040eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-040eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-040eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-040eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
27241-040eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma USA Inc.ANDACurrent
27241-040eletriptan hydrobromideeletriptan hydrobromideAjanta Pharma LimitedANDACurrent
55700-756eletriptan hydrobromideeletriptan hydrobromideQuality Care Products, LLCANDACurrent
55700-756eletriptan hydrobromideeletriptan hydrobromideQuality Care Products, LLCANDACurrent
55700-756eletriptan hydrobromideeletriptan hydrobromideQuality Care Products, LLCANDACurrent
71335-1830eletriptan hydrobromideeletriptan hydrobromideBryant Ranch PrepackANDACurrent
71335-1830eletriptan hydrobromideeletriptan hydrobromideBryant Ranch PrepackANDACurrent